RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

NCT Number	NCT07366840
Lead Sponsor	Fudan University
Conditions	HER2-positive Breast Cancer, Metastatic Breast Cancer
Enrollment	268 participants
Start Date	2026-01-16
Primary Completion	2028-01-16 (estimated)
Study Completion	2029-01-16 (estimated)
Updated on ClinicalTrials.gov	2026-01-26